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RECRUITING
NCT06487533

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

Sponsor: Spark Biomedical, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-02-19

Completion Date

2027-05-31

Last Updated

2026-04-08

Healthy Volunteers

Not specified

Interventions

DEVICE

EmbracePlus Smartwatch

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data can be wirelessly transmitted to a paired mobile device. The data received are analyzed by EmpaDSP, which computes the user physiological parameters. The Care App is responsible for transmitting raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. The device supports continuous data collection for monitoring of the following physiological parameters: * Peripheral skin temperature * Electrodermal activity * Blood Oxygen Saturation under no motion conditions * Activity associated with movement during sleep. The EmbracePlus Watch has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements.

DEVICE

Corti Sensor

The Corti Wearable is a sweat sensor that is worn continuously measure cortisol, melatonin, tumor necrosis alpha interleukin-6 (IL-6) in the protein analytes in the sweat of participants via electrochemical impedance spectroscopy. The Corti Wearable comprises a plastic reader and a replaceable polymer sweat-sensing strip with zinc oxide (ZnO) coated electrodes that is worn on the participant's forearm. It is manufactured through a screen-printing technique that allows for an affinity-based interaction between a capture probe antibody and the target molecule generating electrochemical activity. The Cort Wearable has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements.

Locations (2)

Hazelden Betty Ford Foundation

Center City, Minnesota, United States

Battelle Memorial Institute

Columbus, Ohio, United States